Peripheral T-cell LymphomaPhase 1/2NCT06421948
Linperlisib Combined With Chidamide in Patients With PTCL
A Phase 1/2 study testing Linperlisib and chidamide and cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone in people with Peripheral T-cell Lymphoma, run by Yanyan Liu at 6 sites in China.
Trial summary
The phase Ib part of this study aims to determine the recommended phase II dose （RP2D）of linperlisib in combination with chidamide for the treatment of peripheral T-cell lymphoma (PTCL). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral T-cell Lymphoma
- What is being tested?
- Linperlisib and chidamide and cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 6 sitesChina
- Study dates
- 25 May 2024to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years at the time of inclusion (Age 18-80 years for phase Ib and IIa study)
- Patients with a newly diagnosed and histologically confirmed PTCL (phase Ib study includes both newly diagnosed and relapsed/refractory PTCL). Anaplastic large cell lymphoma, NK/T-cell lymphoma, and primary cutaneous T-cell lymphoma are not included.
- ECOG PS 0-2 at protocol entry
- Estimated life expectancy of 6 months or longer
- Measurable disease
- Hemoglobin ≥ 8 g/dL (≥5 mmol/l); Platelets ≥ 75 x 10E9/L; Absolute neutrophil count ≥ 1.0 x 10E9/L; Platelets ≥ 50 x 10E9/L permitted if documented bone marrow involvement; Serum bilirubin ≤ 1.5 x upper limit of normal (ULN); Serum glutamic-oxaloacetic transaminase (AST) and/or serum glutamic-pyruvic transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN if elevation is due to hepatic involvement by lymphoma; Serum creatinine ≤ 1.5 x ULNb; left ventricular ejection fraction (LVEF) ≥ 50%
- Women of childbearing potential must use safe anticonception (e.g. contraceptive pills, intrauterine devices etc.) during the study and 12 months after the last administration of study drugs; Male patients must use contraception for the duration of the study and 6 months after the last administration of study drugs if his partner is of childbearing potential
- Written informed consent
Who cannot join
- Patients previously treated with PI3K inhibitor
- Patients previously treated with chidamide (phase Ib study is not limited by this item)
- Suspected or documented central nervous system involvement by lymphoma
- Patients with positive HIV and/or active hepatitis B and/or hepatitis C infection
- Patients with active, uncontrolled infections
- Unwillingness or inability to comply with the protocol
Show all 11Show fewer
- Deemed 'unfit' by the treating physician
- Pregnant and/or breastfeeding women
- Concurrent severe and/or uncontrolled medical disease which is not lymphoma-related
- Patients with contraindications to chemotherapy
- Known hypersensitivity to one or more of the study drugs
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Yajun Li
Changsha, Hunan, 410003
Yajun Li, 19918803330, liyajun@hnca.org.cn
- Recruiting
Ming Jiang
Chengdu, Sichuan, 610041
Ming Jiang, 86+028-85422114, jiangming79@wchscu.cn
- Recruiting
Cong Li
Hangzhou, Zhejiang, 310000
Cong Li, Dr., 86+15267115611, licong@zjcc.org.cn
- Recruiting
Huilai Zhang
Tianjin, Tianjin Municipality, 300060
Huilai Zhang, 86+022-23340123, hzhang03@tmu.edu.cn
- Recruiting
Liling Zhang
Wuhan, Hubei, 430022
Liling Zhang, 86+15871725926, 15871725926lily1228@sina.com
- Recruiting
Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou, Henan, 450008
Yanyan Liu, 86-037165587791, yyliu@zzu.edu.cn
Zheng Yan, 86+13598097015, zlyyyanzheng3920@zzu.edu.cn
About this study
Official title: PI3Kδ Inhibitor Linperlisib Combined With HDAC Inhibitor Chidamide Versus CHOP in Patients With Peripheral T-cell Lymphoma: a Multicenter, Open Label, Phase Ib/II Study
The phase Ib part of this study aims to determine the recommended phase II dose （RP2D）of linperlisib in combination with chidamide for the treatment of peripheral T-cell lymphoma (PTCL).
The phase IIa part is designed to evaluate the preliminary efficacy and safety of the linperlisib plus chidamide regimen in newly diagnosed PTCL patients.
The phase IIb part compares the efficacy and safety of linperlisib combined with chidamide versus the standard CHOP (CHOP-like) regimen in newly diagnosed PTCL patients.
Read the detailed description
In the phase Ib trial, participants with newly diagnosed or relapsed/refractory PTCL will receive fixed dose of chidamide (20 mg, twice a week) and escalating dose of linperlisib (40 mg, 60 mg, or 80 mg, once a day), to find out the RP2D.
The phase IIa study is an exploratory efficacy study enrolling newly diagnosed PTCL patients who receive linperlisib in combination with chidamide to evaluate the efficacy and safety of the regimen.
In the phase IIb study, participants with newly diagnosed PTCL will be randomized into experimental arm (arm A) to receive linperlisib in combination with chidamide, or control arm (arm B) to receive standard CHOP (or CHOP-like) regimen chemotherapy.
Interim efficacy assessment will be performed after three cycles of treatment. Responded participants will receive another three cycles of treatment. After a total of 6 cycles of treatment, participants can choose autologous hematopoietic stem cell transplantation, maintenance treatment with linperlisib and/or chidamide, or watch and wait.
- Conditions
- Peripheral T-cell Lymphoma
- Being tested
- Linperlisib and chidamide, cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linperlisib and chidamideDrug
Linperlisib is a selective PI3Kδ inhibitor that has been approved in mainland China for the treatment of relapsed or refractory follicular lymphoma, with a recommended monotherapy dose of 80 mg orally once daily. In this study, Linperlisib was administered at three dose levels of 40 mg, 60 mg, and 80 mg in order to determine the recommended Phase II dose (RP2D) when combined with a fixed dose of Chidamide (20 mg twice weekly).
Chidamide has been approved in mainland China for the treatment of relapsed or refractory PTCL and double-expressor DLBCL. In this study, it was administered at a fixed dose of 20 mg twice weekly in combination with Linperlisib.
Linperlisib and chidamideDrug
All patients received Linperlisib at the RP2D dose once daily and Chidamide 20 mg twice weekly, with each treatment cycle lasting 3 weeks. After three cycles, an interim efficacy assessment was performed. Patients who showed a therapeutic response received an additional three cycles, and the final efficacy evaluation was conducted after six cycles.
Linperlisib and chidamideDrug
Patients received Linperlisib at the RP2D dose once daily and Chidamide 20 mg twice weekly, with each treatment cycle lasting 3 weeks. After three cycles, an interim efficacy assessment was performed. Patients who showed a therapeutic response received an additional three cycles, and the final efficacy evaluation was conducted after six cycles.
cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisoneDrug
Patients receive conventional CHOP (or CHOP-like regimens such as CHOPE or EPOCH) chemotherapy, with 3 weeks for one cycle. After three cycles, an interim efficacy assessment was performed. Patients who showed a response received an additional three cycles, and the final efficacy evaluation was conducted after six cycles.
| Study group | Role | What they receive |
|---|---|---|
| Phase Ib: Dose-escalation cohort | Experimental | Linperlisib was administered in three dose groups of 40 mg, 60 mg, and 80 mg once daily (QD), with each group enrolling 3-6 patients with newly diagnosed or relapsed/refractory PTCL. Chidamide was given at a fixed dose of 20 mg twice weekly. During the 21-day DLT (dose-limiting toxicity) observation period, the maximum tolerated dose (MTD) of linperlisib was assessed, and the recommended phase II dose (RP2D) was determined for use in the phase II study. Receives: Drug: Linperlisib and chidamide |
| Phase IIa: Expansion cohort | Experimental | In newly diagnosed PTCL patients, the efficacy and safety of Linperlisib (RP2D) combined with Chidamide were evaluated. Each treatment cycle is 3 weeks, and patients who responded effectively would receive a total of six cycles of therapy. Receives: Drug: Linperlisib and chidamide |
| Phase IIb: Randomized controlled study: experimental arm | Experimental | Patients randomized to the experimental group will receive combination therapy with Linperlisib and Chidamide. Receives: Drug: Linperlisib and chidamide |
| Phase IIb: Randomized controlled study: Control arm | Active comparator | Patients randomized to the control group will receive conventional CHOP or CHOP-like regimen chemotherapy. Receives: Drug: cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase 2 Dose (RP2D)
Phase Ib
Measured: Approximately 3 months
CRR (Complete response rate)
Phase IIa and IIb
Measured: Through study completion, an average of 3 years
Secondary outcomes (5)
PFS (progression-free survival)
Phase IIa and IIb
Measured: Through study completion, an average of about 3 years
OS
Phase IIa and IIb
Measured: Through study completion, an average of about 3 years
AE (Adverse event)
Phase Ib, IIa and IIb
Measured: Through study completion, an average of 3 years
Physical Functioning and Fatique as Measured by the European Organization for Research and Treatment of Cancer Quality of Life - Core 30 Questionnaire (EORTCQLQ-C30)
Phase IIb
Measured: Cycle 1 Day 1 through follow-up period
Lymphoma Symptoms as Measured by the Functional Assessment of Cancer Therapy -Lymphoma (FACT-Lym) Subscale
Phase IIb
Measured: Cycle 1 Day 1 through follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start25 May 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanyan Liu
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Yanyan Liu, Henan Cancer Hospital
- Investigators
- Yanyan Liu, Principal investigator, A
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421948
- Sponsor's protocol ID
- HNSZLYYML08
- Status last verified
- May 2025
- First submitted
- 6 May 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PI3Kδ Inhibitor Linperlisib Combined With HDAC Inhibitor Chidamide Versus CHOP in Patients With Peripheral T-cell Lymphoma: a Multicenter, Open Label, Phase Ib/II Study
- ClinicalTrials.gov ID
- NCT06421948
- Acronym / sponsor ID
- HNSZLYYML08
- Conditions
- Peripheral T-cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Yanyan LiuOther government
- Study start
- 25 May 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The phase Ib part of this study aims to determine the recommended phase II dose （RP2D）of linperlisib in combination with chidamide for the treatment of peripheral T-cell lymphoma (PTCL).
The phase IIa part is designed to evaluate the preliminary efficacy and safety of the linperlisib plus chidamide regimen in newly diagnosed PTCL patients.
The phase IIb part compares the efficacy and safety of linperlisib combined with chidamide versus the standard CHOP (CHOP-like) regimen in newly diagnosed PTCL patients.
Detailed description
In the phase Ib trial, participants with newly diagnosed or relapsed/refractory PTCL will receive fixed dose of chidamide (20 mg, twice a week) and escalating dose of linperlisib (40 mg, 60 mg, or 80 mg, once a day), to find out the RP2D.
The phase IIa study is an exploratory efficacy study enrolling newly diagnosed PTCL patients who receive linperlisib in combination with chidamide to evaluate the efficacy and safety of the regimen.
In the phase IIb study, participants with newly diagnosed PTCL will be randomized into experimental arm (arm A) to receive linperlisib in combination with chidamide, or control arm (arm B) to receive standard CHOP (or CHOP-like) regimen chemotherapy.
Interim efficacy assessment will be performed after three cycles of treatment. Responded participants will receive another three cycles of treatment. After a total of 6 cycles of treatment, participants can choose autologous hematopoietic stem cell transplantation, maintenance treatment with linperlisib and/or chidamide, or watch and wait.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase Ib: Dose-escalation cohort | Experimental | Drug: Linperlisib and chidamideLinperlisib was administered in three dose groups of 40 mg, 60 mg, and 80 mg once daily (QD), with each group enrolling 3-6 patients with newly diagnosed or relapsed/refractory PTCL. Chidamide was given at a fixed dose of 20 mg twice weekly. During the 21-day DLT (dose-limiting toxicity) observation period, the maximum tolerated dose (MTD) of linperlisib was assessed, and the recommended phase II dose (RP2D) was determined for use in the phase II study. |
| Phase IIa: Expansion cohort | Experimental | Drug: Linperlisib and chidamideIn newly diagnosed PTCL patients, the efficacy and safety of Linperlisib (RP2D) combined with Chidamide were evaluated. Each treatment cycle is 3 weeks, and patients who responded effectively would receive a total of six cycles of therapy. |
| Phase IIb: Randomized controlled study: experimental arm | Experimental | Drug: Linperlisib and chidamidePatients randomized to the experimental group will receive combination therapy with Linperlisib and Chidamide. |
| Phase IIb: Randomized controlled study: Control arm | Active comparator | Drug: cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisonePatients randomized to the control group will receive conventional CHOP or CHOP-like regimen chemotherapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-75 years at the time of inclusion (Age 18-80 years for phase Ib and IIa study)
- Patients with a newly diagnosed and histologically confirmed PTCL (phase Ib study includes both newly diagnosed and relapsed/refractory PTCL). Anaplastic large cell lymphoma, NK/T-cell lymphoma, and primary cutaneous T-cell lymphoma are not included.
- ECOG PS 0-2 at protocol entry
- Estimated life expectancy of 6 months or longer
- Measurable disease
Key exclusion criteria (11 listed)
- Patients previously treated with PI3K inhibitor
- Patients previously treated with chidamide (phase Ib study is not limited by this item)
- Suspected or documented central nervous system involvement by lymphoma
- Patients with positive HIV and/or active hepatitis B and/or hepatitis C infection
- Patients with active, uncontrolled infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Linperlisib and chidamideLinperlisib is a selective PI3Kδ inhibitor that has been approved in mainland China for the treatment of relapsed or refractory follicular lymphoma, with a recommended monotherapy dose of 80 mg orally once daily. In this study, Linperlisib was administered at three dose levels of 40 mg, 60 mg, and 80 mg in order to determine the recommended Phase II dose (RP2D) when combined with a fixed dose of Chidamide (20 mg twice weekly). Chidamide has been approved in mainland China for the treatment of relapsed or refractory PTCL and double-expressor DLBCL. In this study, it was administered at a fixed dose of 20 mg twice weekly in combination with Linperlisib. | Drug | Phase Ib: Dose-escalation cohort |
| Linperlisib and chidamideAll patients received Linperlisib at the RP2D dose once daily and Chidamide 20 mg twice weekly, with each treatment cycle lasting 3 weeks. After three cycles, an interim efficacy assessment was performed. Patients who showed a therapeutic response received an additional three cycles, and the final efficacy evaluation was conducted after six cycles. | Drug | Phase IIa: Expansion cohort |
| Linperlisib and chidamidePatients received Linperlisib at the RP2D dose once daily and Chidamide 20 mg twice weekly, with each treatment cycle lasting 3 weeks. After three cycles, an interim efficacy assessment was performed. Patients who showed a therapeutic response received an additional three cycles, and the final efficacy evaluation was conducted after six cycles. | Drug | Phase IIb: Randomized controlled study: experimental arm |
| cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisonePatients receive conventional CHOP (or CHOP-like regimens such as CHOPE or EPOCH) chemotherapy, with 3 weeks for one cycle. After three cycles, an interim efficacy assessment was performed. Patients who showed a response received an additional three cycles, and the final efficacy evaluation was conducted after six cycles. | Drug | Phase IIb: Randomized controlled study: Control arm |
Primary outcome
Recommended Phase 2 Dose (RP2D)
Time frame: Approximately 3 months
Phase Ib
CRR (Complete response rate)
Time frame: Through study completion, an average of 3 years
Phase IIa and IIb
5 secondary outcomes
PFS (progression-free survival)
Time frame: Through study completion, an average of about 3 years
OS
Time frame: Through study completion, an average of about 3 years
AE (Adverse event)
Time frame: Through study completion, an average of 3 years
Physical Functioning and Fatique as Measured by the European Organization for Research and Treatment of Cancer Quality of Life - Core 30 Questionnaire (EORTCQLQ-C30)
Time frame: Cycle 1 Day 1 through follow-up period
Lymphoma Symptoms as Measured by the Functional Assessment of Cancer Therapy -Lymphoma (FACT-Lym) Subscale
Time frame: Cycle 1 Day 1 through follow-up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yanyan Liu principal investigator
A
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Linperlisib and chidamide and cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone in people with Peripheral T-cell Lymphoma, run by Yanyan Liu at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanyan Liu (86 037165587791, yyliu@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Phase 2 Dose (RP2D) (time frame: Approximately 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.